A Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of ASP1941 in Healthy Male Taiwanese Subjects

Healthy Clinical Trial

Official title:

A Double-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Oral Doses of ASP1941 in Healthy Male Taiwanese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01373060
• Other study ID #: 1941-CL-2001
• Status: Completed
• Phase: Phase 1
• First received: May 31, 2011
• Last updated: October 10, 2011
• Start date: February 2011
• Est. completion date: March 2011

Study information

• Verified date: October 2011
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

This study assesses the safety, tolerability, pharmacokinetics and pharmacodynamics of ASP1941 orally administered as single doses to healthy adult male Taiwanese subjects.

Description:

The subjects will be administered a single dose of ASP1941 or placebo under fasting condition. Plasma and urine levels of ASP1941 and glucose will be measured to investigate pharmacokinetic and pharmacodynamic properties of ASP1941.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Body weight between 50 and 85 kg, and Body Mass Index (BMI) between 17.6 and 26.4 kg/m2 inclusive

Exclusion Criteria:

• Medical history of metabolic disease, hepatic disease, heart disorder, respiratory disease, gastrointestinal disease, renal disease, cerebrovascular disorder, malignant tumor, drug allergy and drug/alcohol dependence

• Blood pressure, pulse rate, body temperature and 12-lead ECG are outside of the preset normal range

• Labo test results deviate from preset normal range

• Receiving treatment, including medication, within 14 days before the study

• Receiving medication in another clinical study or a post-marketing clinical trial within 3 months before the study

• Donates 500mL of whole blood within 3 months or 250mL within 2 months or blood components within 14 days before the study

• Drinking more than 45g of alcohol, or smoking more than 20 cigarettes per day

• Employed by the sponsor, delegated CRO or the study site

• Fasting plasma glucose level of < 70 mg/dL or =110 mg/dL or with an HbA1c =5.8%

• Subjects with positive serology test for Hepatitis B antigen, Hepatitis A virus IgM, anti-Hepatitis C virus or anti-Human Immunodeficiency virus-1 or -2

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy
• Pharmacokinetics of ASP1941

Intervention

Drug:
• ASP1941
oral
• Placebo
oral

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Astellas Pharma Taiwan, Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessed by the incidence of adverse events, vital signs, safety lab tests and 12-lead ECG		up to 72 hours	No
Secondary	Cmax of ASP1941 plasma concentration		up to 72 hours	No
Secondary	AUC (Area under the curve) of ASP1941 plasma concentration		up to 72 hours	No
Secondary	Changes in plasma glucose		baseline and up to 72 hours	No
Secondary	Changes in urine glucose		baseline and up to 72 hours	No